Steerable Catheter Device and Method for The Chemoembolization and/or Embolization of Vascular Structures, Tumours and/or Organs

ABSTRACT

The steerable catheter comprises a flexible tube, inside of which different conducts are arranged: one or more conducts for drug administration, vacuum conducts associated with different radiofrequency electrodes, conducts for the conductive wires that conducts the radiofrequency energy to the distal end of the catheter, conducts for the fibre optic cable/s that conducts the laser energy to the distal end of the catheter, a guiding wire for the catherization, and another components; the steerable catheter being connected from the proximal end to a energy unit and other pressure and/or dosing devices; and the steerable catheter optionally including an inflatable balloon to help occluding the vessel; and it also incorporates one or two electrode/s or conductive layer/s in the distal end of the catheter; the objective of the steerable catheter being the obtaining of better results in the embolization and/or chemoembolization treatments.

This invention pertains generally to the technical sector of thechemoembolization and/or emobilization of vascular structures, ofbenign, premalignant, or malignant tumours, and/or of partial orcomplete organs of a patient.

More particularly the present invention relates to a steerable catheter,which comprises the emission of at least energy from radiofrequencysource and laser source before, during, and/or after the administrationof a chemotherapeutic and/or embolization drug; and also the method ofoperation of the catheter. Additionally, other types of energies can bealso incorporated in the catheter, which are preferably selected fromthe intense pulse light microwaves (IPL) or the high-intensity focusedultrasound (HIFU).

The purpose of the catheter device is energy transfer to the surroundingtissue in order to involve tissue changes and/or environmental changes,which promotes the effect of the administered drug directly and/orindirectly: directly by changing the drug itself structurally, orindirectly by changing the surrounding tissue in region where the drugwas administered. Other changes can result in an increased therapeuticeffect, due to induced necroses to tissue, changes in blood flow(increased, decreased and/or stopped), and a better drug control (higherconcentration, less drug wash out, less backflow) in the treated area.

Tissue ablations techniques with the assistance of different types ofenergy sources are well described in literature. These methods werealready used in the open surgery and invasive treatment. The simplestexample is applying an electric energy source during open surgery fortissue coagulation.

Specifically laser and radiofrequency sources are already usedseparately in an ablative and non-ablative manner. However, in all thesetreatment options the energy is used for a direct energy transfer-tissuecontact interaction, so the only goal of all systems is tissuedenaturation and/or coagulation.

As described in U.S. Patent Application Publication No. 2005/159734A1,it is known an apparatus for treating a biological tissue of a patientin situ comprising an optical fibre for guiding a coherent waveform to afibre tip for discharge of light energy from said fibre tip in adirection of energy discharge, and a guide tip coupled to said fibretip.

In U.S. Pat. No. 4,565,200 an electrode system is described in which asingle entrance tract cannula is used to introduce an electrode into aselected body site.

In order to occlude the vessel an inflatable balloon is generally usedat the distal end of a catheter, as described in U.S. Pat. No. 3,435,826and U.S. Pat. No. 4,762,130.

Also, in the US Patent Application Publication No. 2006/9404 theradiofrequency treatment combined with pharmaceutical compositions isdescribed to ablate tumour masses by means of a needle having one ormore tines, which can comprise a pharmaceutical composition.

Regarding the drug treatments, the present principal problem is the drugwash out and drug control in the treated area, since high concentrationand/or high toxic embolic and/or chemotherapeutic drugs cannot be usedsafely as a systemic and interarterial treatments.

Thus, it exists a patent need to develop a method and apparatus foroptimizing the local drug control once the therapeutic was injected inthe treated area. For example, connection drugs with the other carriersor to antibodies can be used with the aim of changing the molecules, andthese are yet in study.

Nevertheless, tissue interaction for better drug control and/ormodification has not been described or known in the hereby-describedfield. Increasing the drug potentiality by inducing environmentalchanges for example changing temperature, or inducing a local lightsource in tissue can induce a better therapeutic effect. Saidenvironmental changes can also comprise those changes of the surroundingtissue by, for example, inducing changes in blood flow in the treatedarea. These changes can be permanent and/or non-permanent: non-permanentchanges can be vasodilatation and/or vasoconstriction, and/or bloodextraction in the treated area; and permanent changes can bevaso-occlusion, induced tissue necroses, or changes in permeability ofthe tissue barriers and/cell barriers in the treated area. All thesechanges can be induced before, during and/or after drug administration.All the described methods could change the drug-tissue interaction.

Embodiments of the present invention relate to an improved method andapparatus with the aim of obtaining better results in the treatment withembolization and/or chemoembolization.

In addition, the embodiment of the invention relates to a better drugcontrol and/or tissue control in the treated area, to ensure a betterdrug-energy-tissue interaction. By using these assists better resultscould be obtained in the treatment of for example vascular malformationsin tissues, or the treatment of benign and/or malignant tumours.

Therefore, as a result of the present invention, high concentrationand/or high toxic embolic and/or chemotherapeutic and/or immunoactivedrugs, which until now cannot be used systemic and interarterial, willbe able to be used in a safer way.

Therefore, modification and/or activation of the drug by an energysource will result in a new therapeutic window for the treatment of veryaggressive tumours or vascular malformations. For example, accidentaldrug leakage in the non-therapeutic area will be able to be betteravoided. In other cases, by increasing blood flow by vasodilatation itwill be able to obtain an increased drug absorption in tissue.

Additionally, these new devices could simplify remarkably the treatmentprotocols by ensuring complete and effective devices, which can belocated in situ in an organ by catherization, and/or by direct punctureof soft tissue or organs, and in which as well as different energysources as different drugs, and/or vacuum can be administered. Suchthese technologies will enable to treat a wide range of pathologies withless instrumentation for the patient. By using the catheter of theinvention more local invasive techniques in the treated area can beperformed through smaller incisions and a smaller amount of catheters,with a lesser morbidity, lesser traumatic to the surrounding tissue andlesser side effects.

Thus, with these new devices better drug and/or environmental controlwill be obtained with better therapeutic results and better patientsatisfaction or patient survival rates in malignant tumours.

The embodiment of the invention is engineered for human use; however, itcan be also suitable for other species in vivo and/or in vitro and inthe largest sense of the word, and/or in tissue engineering and/orothers.

It is an object of the invention to provide a probe for changing theblood flow in the efferent and afferent vascular system (increased,decreased) to obtain a better drug control and/or drug modification.

It is also object of the invention to provide a probe for changing thesurrounding tissue by changing their barriers (vessel barrier, tissuebarrier, cell barrier).

It is a further object of the invention to provide a probe for changingand/or activating the therapeutic drug. This can be directly and/orindirectly through the tissue interaction.

These and other objects of the present invention will become moreapparent from the discussion below.

According to the present invention, a method and apparatus are disclosedwhich enables reliable and/or controlled destruction of tissue by thecombination of a drug, dye and/or the administration in situ of activeand/or non active particles and/or substances, liquids, gases and othersor a combination of these mentioned above with an energy source andcontrasts.

The apparatus comprises essentially a catheter, which incorporatesdifferent drug conduits and vacuum conduits associated with differentelectrodes, radiofrequency conduits, optical fibres and othercomponents, and the apparatus is connected with an energy unit. Inaddition, an inflatable balloon is provided at the distal end of thecatheter to help occlude a vessel. The energy assist embolizationcatheter embodiments of the invention can also incorporate the necessarydevices to introduce the catheter in an anatomical site in the treatedarea or at a distance of the site. This instrumentation can enable thephysician to expose the active distal end in the therapeutic area bydifferent techniques: tunnelling, catherization and/or dissection,and/or direct puncture. In order to place the catheter in the treatedarea different energy sources and/or energy conduits, which wereintroduced in and/or built in the catheter can be used. Thereby thephysician can dissect, coagulate and ablate tissue with optimum results.Other devices that can be incorporated in the catheter are: a guidewire, sheets, distractors.

The catheter according to the invention comprises an elongated flexibletube inside of which a plurality of conduits and wires go through untilthe distal end of the catheter: at least one conduit for drugadministration, an optical fibre cable inside of which comprises one ormore optical fibres to pass on the laser light, and a guiding wire tocarry the catherization out. Preferably, one or two electrodes/s orconductive layers can be positioned on the outer surface of the catheterdistal end to emit radiofrequency waves generated by a radiofrequencysource at the distal end of the catheter. Each of these electrodes isconnected to a conductive element, which is electrically coupled to aradiofrequency generator.

Optionally, a guiding mechanism can also be incorporated within theflexible catheter tube; said guiding mechanism being formed of at leastone steering or pull cable.

Furthermore, the described catheter can also include at least oneinflatable balloon with its corresponding conduits forinflating/deflating said balloon. Each balloon requires at least oneconduit to obtain the inflation or deflation of it, which forms anindependent lumen.

Alternatively, inside the catheter tube a conduit for a dye or otherliquids such as refrigerating fluids to refrigerate the electrodes canbe provided.

Alternatively, inside the catheter tube delivery devices for otherenergies' transmission can be incorporated. These energy sources, whichcan be connected to the probe, can have different wavelengths, bedifferent types of light sources or be other types of energy.

Therefore, in accordance with the above mentioned, the distal end ofsaid catheter comprises at least one independent lumen for the drugadministration, one central lumen for the guiding wire, one lumen forthe optical fibre/s and another lumen for the radiofrequency energywire; and at least one electrode placed on or near to the distal end ofthe catheter.

The balloon/s quoted above is/are placed in the vicinity of said distalend and can be positioned not only in target tissue or organs, cavities(such the thorax, sinu) or conduits (arterial, venous), but also forexample in hepatic duct, or urethra etc. The inflation of the ballooncan alter the flow in the conduit, can prevent leakage of an injectedagent, or can create a physical separation, compression, or shield intissue.

Preferably, the electrical wire/s for activating the electrode/s and theoptical fibre cable which contains the optical fibre/s will locate closeone to each other in order to reduce the catheter tube's diameter andmake the catheter compacter and easier to use.

In reference to the radiofrequency source, one or two conduits or lumensfor said electrical wires are used, this to use the system as a uniqueor bipolar unit. If a unipolar configuration is used, the groundelectrode is placed apart from the catheter distal end.

Said electrical wire/s may be fabricated from one or more lengths oftubing, secured at to the tube or advantageously at other energyconduits such as an optic fibre.

Different electrodes can be isolated with insulating material. Saidelectrode can have different configurations on cross-section, and evencoiled into a helix. The electrode can be incorporated into a mesh, orcan include lengths of sheet or bar material to an other support, havinga semicircular configuration or other geometry thereby forming a part ofand/or a complete lumen which can be uses for example to mount the opticfibre. Other geometric forms are possible for the electrodes, such asconcentric configuration.

The electrode itself can be fabricated from any metal (for example gold,platinum or tungsten), metal deposits over a carrier (gold-platedstainless steel, gold deposited polyamide or platinum depositedpolyester). This carrier can be incorporated or be an effective othercomponent of the catheter and can be very malleable, must be resistantto external forces, must bend this allowing catherization.

The catheter has at least one or more optical fibres. These can be inindependent conduits or can be coupled. It is important that the lightdiffusing energy into the human tissue is in a uniform manner. Theenergy is diffused radially and outwardly in a uniform distributionalong the entire length of the fibre assuring a proper heating or energydistribution at the therapeutic end.

The optical fibre will be connected to a laser source, which is locatedout of the catheter, and in collaboration with the selected connectiondevices.

At the distal end of the catheter temperature and/or Doppler probes canbe associated with the existing electrodes, in order to measure thetemperature and the blood flow respectively.

One possible embodiment for a communal lumen where bipolar electrodesare used is providing an inner electrode and an outer electrode ofcylindrical configuration at a concentrical position, between of whichseveral optical fibres are arranged.

Another possible embodiment for a communal lumen where bipolarelectrodes are used is having two electrodes with U-shaped sectionsituated face to face, in between of which several optical fibres arearranged.

In both previous options, the optical fibres are arranged in the spacebetween the two bipolar electrodes, so acting advantageously as aninsulating element for the bipolar electrodes.

Preferably, said steering or pull wire/s, which function is to guide thedistal end of the catheter, locate near the electrodes and opticalfibres in order to optimize the steering of the distal end. The steeringor pull wire end is radio opaque or echo opaque.

Extra markings for navigation and mapping can be added (e.g. fordetection by infrared camera, MRI, CT related procedures).

The steerable catheter can also incorporate an information center unit,which is an electronic device that measures different catheter currentparameters of the catheter, such as the pipe, the current use or thewave flanges. Said information center unit is located near the proximalend of the catheter and it is connected to the energy generator unit totransmit the measuring parameters to the generator.

The central lumen of the catheter receives the guiding wire forcatherization. Through this lumen active or non-active substances can beadministered. This part of the catheter can be connected to a volumetricpump for perfusion of the probe or probe cooling or other purposes.Through this conduit measurement probes or energy probes can also beintroduced. The connector has a valve mechanism and luer adaptor.

At the proximal end of the catheter the conduits join into a handle thatincorporates the different ports to the different units of the catheter,and a steering mechanism of the distal end of the catheter. Certain ofthese ports incorporate a luer adaptor, or another tubing or anelectric, or a fibre, or another connection, capable of transmitting thenecessary source of energy or substance.

The handle incorporates at least one or more conduit to supply theenergy on the catheter therapeutic end. The conduits are connected tothe energy source by a connection device.

The multi-conduit catheter and its additional structures can befabricated from different raw materials having the desiredqualifications, the desired pattern, cross sectional profile, anddimension. It can contain rod, wire, tubes, sheets, ribbons, opticalfibres etc. These raw materials can be fabricated by extruding,injection moulding, forging, rolling, casting and others to obtain theright shape and configuration. The different elements of the cathetermay be cut from raw material by water jet cutting, laser cutting, UScutting, EDM machining, photochemical etching, or others to obtain thelumens, pores, ports, and other features from the raw material. All thedifferent components of the catheter can be assembled and/or unified bylaser welding, adhesive bonding, ultrasonic welding, radiofrequencywelding, soldering, spot welding, or other means.

Various components of the probe, which can be fabricated from at leastone wire, tube, ribbon, sheet, rod, band or bar of raw material, whichwere cut the desired configuration, can be thermally changes into thedesired 3-dimensional configuration. During the fabrication thecomponents can be stressed into the resting configuration form usingmandrels and/or forming fixtures, having the desired resting shape ofthe puncturing components and heated to a temperature between 300 and650 degrees Celsius for a predetermined period of time. Once thematerial has reached the desired temperature for desired period, thecomponent is quenched and chilled by different methods, and/or gases,and/or liquids.

Components from the catheter can have different patterns to allow thecorrect geometry for assemblage. These can be oval, circular,rectangular, square, trapezoid, and others. These elements can be cut tothe desired length and stressed to the desired shape by differentmanufacturing proceeds as mentioned above.

The different components of the catheter can be tumbled, sand blasted,bead blasted, chemically etched, ground, mechanically polished, electropolished, or otherwise treated to remove any edges and/or procedure asmooth surface.

To tailor the stiffness profile of the components of the catheter, holesnotches, cut away areas, and others can be performed. The techniques toperform these changes are described above; and by means of these changeswe can change the stiffness profile of regions and/or complete parts ofthe catheter. These changes can be for example in function of the lengthof the catheter to reinforce specific regions and/or to customize partsof the catheter. Certain parts of the catheter can be coated with radioor echo opaque materials.

Additional markings can be added in order to make navigation techniquepossible.

In reference to the tubular shaped body of the catheter, it can befabricated from a metal, metal alloy, PEBAX.RTM, polyester,polyurethane, urethane, silicone, polyamide, other thermoplastic,thermoset plastic, or elastomer, or braided metallic wires covered withpolymer. Said tubing(s) may have a circular, elliptical, or anygeometry, this depending on the stiffness, configuration of thedifferent parts, and assemblage.

In reference to the inflatable balloon, the substance to be used in theinflatable balloon conduits and balloon can be a gas or liquid or amixture. The liquid can be an active agent, or can be a substanceabsorbing light or diffusing light. It can be air, water, oil, contrastagents, perflueocarbons, saline solutions, dyes, etc.

For deflation and inflation and for the maintenance of a calibratedvolume there is at the end of the in(de)flate member a valve. On thevalve a syringe or other calibrated dispenser can be connected, thedispenser can work by volume or by pressure. Advantageously by usingpressure and volume data information can be obtain of the target area.

The shaft of this part of the catheter can be manufactured of differentmaterials selected in the group of the stainless steel, polyamide,polyethylene, polystryren, polycarbonate, extrudable polymer,thermoplastic, silicone, rubber, composite, brass, titanium, aluminium,ceramic etc; This list is not limitative.

The inflatable member can be made of an inelastic or elastic material.In case of elastic material the balloon can take the shape of the targettissue, conduit, or space. In case of an inelastic configuration thetissue, or conduit, or space will take the form of the inflated member.Said inflated member can have any configuration in size or shape, andpreferably its shape can be spherical, ovoid, elliptical, cylindricaland other. The wall of the balloon must be supple enough to change insize and configuration as the introduced substance volume is changed,but at the same time it must be also stiff enough to be manipulatedduring instrumentation and placement, and finally it must be resistantto high pressure and temperature.

The inflatable member can be manufactured from material selected in thegroup of silastic, silicone, c-flex, polyester, mylar, polyurethane,polyvinyl, polyethylene, latex, rubber; this list is not limitative.

The following is descriptive of certain embodiments of the invention.The descriptive cannot be taken in the limited sense, but is made toillustrate the general principles of the invention.

A list of the various references used to describe the embodimentscarried out on the apparatus of the present invention follows:

-   -   (10) catheter;    -   (11) proximal end;    -   (12) distal end;    -   (13) handle;    -   (14) conduit for the balloon;    -   (15) guiding wire;    -   (16) electrical connector;    -   (17) radiofrequency source;    -   (18) balloon connector;    -   (19) pressure device connector;    -   (20) pressure device;    -   (21) conduits for drug;    -   (22) drug connector;    -   (23) drug applicator;    -   (24) optical fibre conduit;    -   (25) optical fibre connector;    -   (26) laser energy source;    -   (27) catheter tube;    -   (28) inflatable balloon;    -   (29) optical fibre;    -   (30) electrode;    -   (31) central opening;    -   (32) side opening;    -   (33) steering cable;    -   (34) energy lumen;    -   (35) outer electrode;    -   (36) inner electrode;    -   (37) U-shaped section electrode;    -   (39) energy connector;    -   (40) conduit for dye;    -   (41) steering mechanism;    -   (42) valve;    -   (43) volumetric pump;    -   (44) central lumen for guiding wire;    -   (45) electric conduits; and    -   (46) radiofrequency lumen.

FIG. 1 a-1 c depicts a partial view of three different embodiments ofthe proximal end (11) and the handle (13) of a catheter embodiment ofthe invention.

FIG. 2 depicts a longitudinal-sectional view of the distal end (12) of acatheter embodiment of the invention.

FIG. 3 depicts a cross-sectional view across line A-A′ of the embodimentof the invention in FIG. 2.

FIG. 4 depicts a longitudinal-sectional view of the distal end (12) ofanother catheter embodiment of the invention.

FIG. 5 shows a cross-sectional view across line B-B′ of the embodimentof the invention in FIG. 4.

FIG. 6 shows a longitudinal-sectional view of the distal end (12) offurther catheter embodiment of the invention.

FIG. 7 shows a cross-sectional view across line C-C′ of the embodimentof the invention in FIG. 6.

FIG. 8 shows a longitudinal-sectional view of the distal end (12) offurther catheter embodiment of the invention.

FIG. 9 shows a cross-sectional view across line D-D′ of the embodimentof the invention in FIG. 8.

FIG. 10 shows a longitudinal-sectional view of the distal end (12) offurther catheter embodiment of the invention.

FIG. 11 shows a cross-sectional view across line E-E′ of the embodimentof the invention in FIG. 10.

FIG. 12 shows a longitudinal-sectional view of the distal end (12) offurther catheter embodiment of the invention.

FIG. 13 shows a cross-sectional view across line F-F′ of the embodimentof the invention in FIG. 12.

FIGS. 1 a-1 c illustrate the catheter proximal end (11) comprising ahandle (13), at one end of which the catheter tube (27) is connected andat the opposite end the different ports (47) where the differentconduits and wires are connected, in order to arrange all the elementsin the proper way within the catheter tube (27). At least a conduit (21)for drug administration, an energy conduit (34) for containing theenergy elements and a guiding wire conduit (44) for containing theguiding wire (15) are steered towards the interior of the body (27) ofthe catheter (27). Additionally, a conduit (14) for theinflation/deflation of the balloon (28) can also be incorporated andalso a steering mechanism (41).

At the end of the guiding wire conduit (44) for the guiding wire (15)and other substances a volumetric pump (43) is incorporated forperfusion of the probe or probe cooling. Additionally, the respectiveconnector has a valve (42).

At the end of the conduit for the balloon (14) a connector (18) isprovided, in order to join said conduit (14) with a pressure device(20), for example a pump or similar, which function is theinflation/deflation of the balloon (28).

At the end of the conduit for the balloon (14) a balloon connector isprovided to connect with a pressure device (20), such as a pump orsimilar, which function is the inflation and the deflation of theballoon depending on the required configuration.

At the end of the energy conduit (34) an energy connector (39) isprovided, the inputs of which are an electrical connector (16) and anoptical fibre connector (25), which both are also connected to thecorresponding energy sources: the radiofrequency source (17) and thelaser energy source (26) respectively.

The distribution of the different ports (47) in the handle (13) can beany, for example the ports (47) being arranged in the same side, as itis shown in FIG. no. 1 b, or being arranged in both sides of the handle(13), as it is shown in FIG. no. 1 c.

Referring to the embodiment of a catheter (10) as shown in FIGS. no.2-3, the distal end (12) of a steerable catheter (10) may compriseessentially a flexible tube (27) inside of which a plurality of conduitsand wires go through, thus forming the multi-lumen catheter. In thisparticular embodiment of a catheter (10), which is the simplest one, alumen for drug administration (21), a radiofrequency lumen (46) for theelectric conduits (45) for activating the polar electrodes (30), a lumen(24) for the transmission of the laser energy inside of which comprisestwo optical fibres (29), a central lumen (44) for the guiding wire (15)and a steering cable (33) with a circumferential perimeter thatsurrounds the rest of the quoted lumens.

Furthermore, in this particular embodiment, an inflatable balloon (28)is also provided, which is inflated/deflated by means of a substancethat flows inside the two conduits (14) and being steered by thepressure device (20).

Optionally, inside the catheter tube (27) a lumen for a dye (40) orother liquids, which is not shown in the figures, such as refrigeratingfluids to refrigerate the electrode/s can also be incorporated.

The distal end (12) of the catheter (10) has two different openings: twoside openings (32) for the drug (21) and dye (40) conduits, and acentral opening (31) for the energy conduits (46) and (24) and the wires(15) and (33) located in a central part of the end of the catheter tube(27).

Referring to FIGS. 4-5, there is shown a second example of the distalend (12) of a steerable catheter (10) comprising a flexible tube (27)inside of which a plurality of conduits and wires go through, thusforming at the end a multi-lumen catheter (10). In this embodiment, twoconduits for drug (21) are provided, as well as a steering cable (33)and a balloon (28) with its respective conduits (14). However, thespecial feature of it is the energy lumen (34), which is a communallumen inside of which there is the central lumen (44) for the guidingwire (15) in a central position surrounded by optical fibres (29). Atthe end of said energy lumen (34) a bipolar electrode is placed; theinner electrode (36) is the outer wall of the central lumen (44), whichis a conductive layer, whereas the outer electrode (35) is located in aconcentrical position regarding the inner electrode (36) in the outerlayer of the lumen (34). Between the bipolar electrodes (35-36) severaloptical fibres (29) are arranged, which act as an insulating material.

In a variation of this embodiment of the multi-lumen catheter (10), asshown in FIG. 6-7, it also incorporates two conduits for drugadministration (21), a balloon (28) with its corresponding conduits(14), two steering cable (33) and a common energy lumen (34). But saidcommon energy lumen (34) has another configuration; the central lumen(44) for the guiding wire (15) is located in a central position and itsouter wall is not active. Thus, there are two bipolar electrodes with aU-shaped section (37) configuration and they are located close to theouter surface of the lumen (34), one in front of the other, between ofwhich several optical fibres (29) are arranged.

As illustrated in FIGS. no. 8-9, another embodiment of the multi-lumencatheter (10) is disclosed. It also includes a common energy lumen (34)with a bipolar U-shaped section electrodes (37) and a central lumen(44), but said electrodes (37) are located close to the inner surface ofsaid conduit (34).

In reference to FIGS. no. 10-13, it is shown two different embodiments,where the drug (21) or dye (40) conducts reach the end of the tubularbody (27) of the catheter (10). The distal end (12) of the catheter (10)has four independent lumens: the central one is the energy lumen (34)and the peripheral lumens are for drug (21) or dye (40). The centralenergy lumen (34) has a symmetric triangular cross section, and in thespace between the walls of the triangle and the walls of the tubularbody (27) there are three independent lumens with a curved crosssection. At the vertexes of said triangle a steering cable (33) isprovided in order to guide perfectly the distal end (12) of the catheter(10). The central lumen (44) is situated in a central position of saidenergy lumen (34) and its outer wall is the inner electrode. The outerelectrode is placed within the energy lumen (34) and in a concentricalconfiguration. Inside of the triangular energy lumen (34) severaloptical fibres (29) are placed.

In FIGS. 12-13, the distal end (12) of the multi-lumen catheter (10) hasa very similar configuration to the previous embodiment, but with thedifference that the outer electrode is placed close to the inner surfaceof the catheter tube (27).

Although the present invention has been described with reference to thepreferred embodiments, workers skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention.

1-37. (canceled)
 38. A steerable catheter used for the chemoembolizationand/or embolization of vascular structures, tumours and/or organs,comprising a flexible tube having a distal and a proximal end, which isprovided with a plurality of lumens, said proximal end of the catheterbeing attached to a handle comprising a plurality of ports for theconnection and introduction of the plurality of elements in thecorresponding lumens, one lumen is used for receiving the guiding wirefor the catherization, and optionally it also includes an obturatoryballoon disposed near the distal end of the catheter and another lumenfor steering the substance that inflates and deflates said balloon,characterized in that it also comprises: at least one lumen for drugadministration disposed along the catheter, from the proximal end to thedistal end of the catheter, said lumen adapted to transfer drug to thetarget tissue; and at least one common lumen or two independent lumensfor the energy elements, said lumen/s disposed along the catheter, fromthe proximal end to the distal end of the catheter, said energy elementsadapted to transfer energy to the surroundings of the target tissue tointeract with the administrated drug; said energy elements comprising:at least one conductive wire disposed along said common or independentlumen to the distal end of the catheter, and at least one electrodepositioned on or near on the end of the distal end of the catheter, andat least one fibre optic cable disposed along said common or independentlumen to the distal end of the catheter.
 39. The steerable catheter ofclaim 38, wherein a steering system is included located, which comprisesat least one steering cable, located on the inside of the tubular bodyof the catheter and extended right to the distal end of the catheter.40. The steerable catheter of claim 38, wherein the optical fibre/sis/are connected to a laser source by means of the selected connectiondevices, such as a connector.
 41. The steerable catheter of claim 38,wherein the electrical wire/s is/are connected to a radiofrequencysource with the selected connection devices, such as a connector. 42.The steerable catheter of claim 38, wherein the drug conduit/s is/areconnected to a drug applicator with the selected connection devices,such as a connector.
 43. The steerable catheter of claim 38, whereintemperature probes and/or Doppler probes can be incorporated at thecatheter distal end of the catheter with the electrodes.
 44. Thesteerable catheter of claim 38, wherein the distal end configuration ofthe catheter has three independent lumens: one lumen for drugadministration, another lumen for the electrical wire/s ofradiofrequency, another lumen for the optical fibre/s, and anothercentral lumen for the guiding wire; at least one electrode disposed onor near the end of the catheter; and one or more steering cable/s. 45.The steerable catheter of claim 38, wherein the optical fibre lumencomprises at least one optical fibre to conduct the laser energy at thedistal end of the catheter.
 46. The steerable catheter of claim 38,wherein the electrical wire lumen comprises at least one electrical wireto conduct the radiofrequency waves to the distal end of the catheterand activate the electrode/s or the conductive layer/s.
 47. Thesteerable catheter of claim 38, wherein the steering cable has across-section with a circumferential perimeter and is positionedsurrounding the rest of the lumens of the catheter.
 48. The steerablecatheter of claim 38, wherein the distal end configuration of thecatheter has at least three independent lumens: at least one independentlumen for the drug administration, a common lumen that contains all theelements involved in the energy transmission (radiofrequency and laserenergy), and a central lumen disposed in a central position inside decommon lumen; two bipolar electrodes disposed on or near the end of thecatheter and a steering cable; and at least one steering cable.
 49. Thesteerable catheter of claim 38, wherein the common lumen has a circularcross-section and comprises a bipolar electrodes having a cylindricalconfiguration and said electrodes being arranged in a concentricalposition, being the inner electrode the outer active wall of the centrallumen, and several optical fibres taking up the space between theelectrodes.
 50. The steerable catheter of claim 38, wherein the commonlumen comprises a bipolar electrodes having a U-shaped cross-section andlocated in a central near to the inner wall of the common lumen, oneelectrodes in front of the other, and the outer wall of the centrallumen being non-active; and several optical fibres taking up the spacebetween the electrodes.
 51. The steerable catheter of claim 38, whereinthe distal end configuration of the catheter has five independentlumens: three lumens for the drug administration or for other liquids ordyes, a triangular cross-section common energy common that contains allthe elements involved in the energy transmission, a central lumenlocated in a central position of the interior of the common lumen; twobipolar electrodes disposed on or near the end of the catheter; and atleast one steering cable.
 52. The steerable catheter of claim 38,wherein the bipolar electrodes have a circular cross-section and theyare arranged in concentrical position: the outer electrode is located innear the inner wall of the tubular body of the catheter and the innerelectrode is the outer wall of the central lumen; and several opticalfibres taking up the space between the electrodes.
 53. The steerablecatheter of claim 38, wherein the bipolar electrodes have a circularcross-section and they are arranged in concentrical position: the outerelectrode is located in near the outer wall of the tubular body of thecatheter and the inner electrode is the outer wall of the central lumen;and several optical fibres taking up the space between the electrodes.54. The steerable catheter of claim 38, wherein the catheter can includea drug concentration device on the delivery site of the drug.
 55. Thesteerable catheter of claim 38, wherein the catheter can be used in thearterial or venous system, in lumen, in cavities, in organs and/or canbe directly used by tissue puncture.
 56. The steerable catheter of claim38, wherein the distal end of the tubular body of the catheter isprovided with two types of openings: Lateral openings to permit the exitout of the catheter tube of the drug and dye conducts, said lateralopenings located in a front position of the catheter tube; and A centralopening to permit the exit out of the catheter tube of the energy(radiofrequency and laser) conducts, the guiding wire and the steeringcable/s.
 57. A method for operating a catheter, comprising: theadministration of a chemotherapeutic and/or embolization drug in thetreated area of vascular structures, of benign, premalignant, ormalignant tumours, and/or of partial or complete organs; and theapplication of a combination of at least two energy sources duringand/or after the administration of the drug.
 58. The method of claim 57,wherein the two energy sources are radio-frequency signal and laserlight energy.
 59. The method of claim 57, wherein the laser energy isgenerated in a laser generator and is conducted to the distal end of thecatheter by means of at least one optical fibre.
 60. The method ofclaims 57, wherein the radio-frequency signal is generated in aradio-frequency generator and is conducted to the end of the catheter bymeans of at least one electrical wire and one electrode.
 61. The methodof claim 57, wherein complementary energy sources are intense pulselight energy source or heat energy source, microwaves and/orhigh-intensity focused ultrasound.
 62. The method of claim 57, whereinthe complementary energies comprise a generator and leading means to thedistal end of the catheter.
 63. The method of claim 57, wherein thedifferent energies can be delivered in independent or common lumen. 64.The method of claim 57, wherein the energy delivery device includes oneor more drug and/or embolization catheter(s) and/or a catheter where avacuum source can be placed.